RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Sleep in Pediatric Patients With Attention Deficit/Hyperactivity Disorder, Phase II
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Sleep Efficiency
研究概览
简要总结
The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are:
Does 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and/or objectively measured attention more than placebo?
Researchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD.
Participants will:
- Take iron supplements every day for 3 months
- Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention
- Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment
详细描述
Study Population Seventy youth (n=70) will be recruited for participation in the proposed study. Youth meeting eligibility criteria will be recruited through Kennedy Krieger Institute's Sleep Disorders Clinic and Center for Neuropsychological and Psychological Assessment (CNaP). Recruitment will be accomplished by posting flyers with study information at the clinics, by reviewing medical record information of upcoming patients to determine potential eligibility, and by asking clinicians to discuss the study with their patients who may be eligible and their caregivers.
Study Design A double-blind, placebo-controlled randomized superiority trial design will be used in this study. Seventy participants will be assigned to treatment and control conditions using permuted block randomization, based on sequential enrollment and equal allocation to study conditions. Both the participant and members of the study team involved in data collection or outcomes assessment will be blinded to the participant's treatment assignment. The treatment interval for the study will be 3 months, which has been sufficient in previous studies to allow for treatment effects to be observed. Pre-treatment and post-treatment, the following data will be collected for each participant:
1) a complete iron blood panel; 2) 14 consecutive nights of actigraphy monitoring using the RestEaze device at home; 3) parent- or self-ratings of sleep quality over the same 14 nights on which the device is worn; 4) ratings of ADHD symptoms(ADHD-RS-V5) completed by parent and teacher; 5) ratings of sleep problems completed by parent; and 6) neuropsychological testing of attention.
Study Treatment Iron supplementation. The NatureMade brand of iron supplement will be administered to all participants in the treatment condition to minimize variability in concentration of the active ingredients across brands/preparations of iron supplements. This brand of iron supplement is independently verified by United States Pharmacopeia (USP), which conducts rigorous evaluation and monitoring of dietary supplements to ensure that they contain the necessary ingredients at the dosages that are claimed by the manufacturer. Dosing will be determined for each participant by the study physician based on weight. All NatureMade pills will be over encapsulated by the Johns Hopkins Investigational Drug Service to ensure treatment blinding for patients. At the conclusion of study participation, participants will work with their physician to determine whether iron supplementation should be continued.
Placebo. Placebo pills will be manufactured by the Johns Hopkins Investigational Drug Service to match the appearance of the over encapsulated NatureMade pills. At the conclusion of the study, participants assigned to the placebo condition whose blood ferritin levels remain under 50ng/mL will be offered a free 3-month supply of the NatureMade active iron treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed with ADHD
- •have blood ferritin level below 50ng/mL
- •have parent- or self-reported restless sleep
排除标准
- •presence of any chronic medical or genetic condition that could impact iron metabolism
- •presence of moderate to severe Obstructive Sleep Apnea
- •having received Iron supplementation treatment within the past 3 months
- •having blood ferritin level indicative of anemia that requires immediate treatment
研究组 & 干预措施
Iron supplementation arm
Participants in the iron supplementation arm will receive 3 months of iron supplementation treatment
干预措施: Ferrous Sulfate (Dietary Supplement)
Placebo arm
Participants in the placebo arm will receive 3 months of placebo treatment
干预措施: Placebo (Other)
结局指标
主要结局
Sleep Efficiency
时间窗: Sleep efficiency will be assessed nightly for 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.
Sleep efficiency refers to the proportion of time in bed spent sleeping and is measured via actigraphy monitoring. Higher scores indicate more efficient/better sleep.
次要结局
- Total sleep time(These will be assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.)
- Wake after sleep onset(These will be assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.)
- Latency to sleep onset(Assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.)
- Attention Deficit Hyperactivity Disorder-Rating Scale-V, parent version(Completed at baseline and again within 2 weeks post-treatment.)
- Attention Deficit Hyperactivity Disorder-Rating Scale-V, self report(Completed at baseline and again within 2 weeks post-treatment.)
- Conners Continuous Performance Test (CPT), 3rd edition(Completed at baseline and again within 2 weeks post-treatment.)
- Children's Sleep Habits Questionnaire(Completed at baseline and again within 2 weeks post-treatment.)
- Sleep Quality Scale(Completed daily for 2 weeks at baseline and then again daily for 2 weeks post-treatment.)
- Wechsler Intelligence Measures, Cancellation Subtest(Completed at baseline and again within 2 weeks post-treatment.)
- NIH Toolbox Flanker Task(Completed at baseline and again within 2 weeks post-treatment.)
- NIH Toolbox Dimensional Change Card Sort task(Completed at baseline and again within 2 weeks post-treatment.)